Official recall record

Philips Azurion Rystem, Model Numbers: 722063, 722064, 722067, 722068, 722078, 722079, 722221, 722222,722223, 722224, 722225, 722226, 7222

US FDA — Medical Devices · 2026-07-16 · NetherlandsClass II

Issuing authority: US FDA — Medical Devices
Alert date: 2026-07-16
Country of alert: Netherlands
Alert level: Class II
Alert type: recall
Barcode (EAN/GTIN): 00884838099258
Brand on record: PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.

What the authority reported

Two software related issues affecting Azurion R2.2.10 Systems: 1) Potential image quality degradation that may lead to delay of therapy, procedural complications and/or inappropriate treatment and 2) Potential loss of geometry movements that may lead to delay of therapy and procedural complications

What to do

Follow the instructions in the official notice — recall remedies (refund, repair, replacement, or disposal) are defined by the issuing authority and the responsible business, and they differ per recall. Do not rely on summaries, including this one.

Verify at the source: US FDA — Medical Devices — official record →
Record last checked against the registry on 2026-09-16.

More recalls: US FDA — Medical Devices · Netherlands · all filters

Same barcode in other registries

The same EAN appears in 3 other official recall record(s) — a cross-border signal worth checking if you bought this product abroad.

2021-09-24 · US FDA — Medical Devices
Philips Azurion Interventional Fluoroscopic X-Ray System, Software version 2.1.x, Model numbers 722063, 722064, 722067,
2025-01-13 · US FDA — Medical Devices
Azurion 7 M20 System code: (1) 722224 (2) 722079 (3) 722234 (4) 722282 System Code: (1) 722078 (2) 722223
2023-12-07 · US FDA — Medical Devices
Philips Azurion 7M20, Model Numbers: 722079, 722224 with Software release R2.2.0, R2.2.1, R2.2.3, R2.2.5 and R2.2.6 wit

Other recalls from this brand

2026-07-16 · US FDA — Medical Devices
Philips Azurion, Model Numbers: 722229, 722230, 722231, 722232, 722233, 722234, 722235, and 722236, with Soft
2026-04-30 · US FDA — Medical Devices
Azurion system; System Code Description (Model Numbers): Azurion 3 M12 (722063, 722221), Azurion 3 M15 (722064

ProductGuru Recalls republishes official safety information with attribution. We are not the issuing authority and this page is not advice. If this product is a medical device or medication, speak to a doctor or pharmacist. Found an error? Report it — corrections are published.